Recall of Statspin Express 4 Centrifuge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by StatSpin, Inc., dba Iris Sample Processing.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57446
  • Event Risk Class
    Class 2
  • Event Number
    Z-2169-2011
  • Event Initiated Date
    2010-08-18
  • Event Date Posted
    2011-05-10
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Centrifuges, (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • Reason
    Rotors may fail due to wire spokes breaking.
  • Action
    Iris notified customers by letter in August 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to install the new rotors and discard the older rotors with the wires. There was no need for customers to return the rotors, but the firm requested customers fax or e-mail the enclosed form to verify that they have installed the new rotors. For any questions customers should call 1-800-782-8774.

Device

  • Model / Serial
    Serial Numbers: 737M51000100 737M51000101 737M51000102 737M51000103 737M51000104 737M51000105 737M51000106 737M51000107 737M51000108 737M51000109 737M51000111 737M51000112 737M51000113 737M51000114 737M51000115 737M51000116 737M51000117 737M51000118 737M51000119 737M51000120 737M51000121 737M51000122 737M51000123 737M51000124 747M51000125 747M51000127 747M51000128 747M51000129 747M51000130 747M51000131 747M51000132 747M51000133 747M51000134 747M51000135 747M51000136 747M51000137 747M51000138 747M51000139 747M51000140 747M51000141 747M51000142 747M51000143 747M51000144 747M51000145 747M51000146 747M51000147 747M51000148 747M51000149 751M51000150 751M51000151 751M51000152 751M51000153 751M51000154 751M51000155 751M51000156 751M51000157 751M51000158 751M51000159 751M51000160 751M51000161 751M51000162 751M51000163 751M51000164 751M51000165 751M51000166 751M51000167 751M51000168 751M51000169 751M51000170 751M51000171 751M51000172 751M51000174 752M51000175 752M51000176 752M51000177 752M51000178 752M51000179 752M51000180 752M51000181 752M51000182 752M51000183 752M51000184 752M51000185 752M51000186 752M51000187 752M51000188 752M51000189 752M51000190 752M51000191 752M51000192 752M51000193 752M51000194 752M51000195 752M51000196 752M51000197 752M51000198 752M51000199 802M51000201 802M51000202 802M51000203 802M51000204 802M51000205 802M51000206 802M51000207 802M51000208 802M51000209 802M51000210 802M51000211 802M51000212 802M51000213 802M51000214 802M51000215 802M51000216 802M51000217 802M51000218 802M51000219 802M51000220 802M51000221 802M51000222 802M51000223 802M51000224 805M51000225 805M51000226 805M51000227 805M51000228 805M51000229 805M51000230 805M51000231 805M51000232 805M51000233 805M51000234 805M51000235 805M51000236 805M51000237 805M51000238 805M51000239 805M51000240 805M51000241 805M51000242 805M51000243 805M51000244 805M51000245 805M51000246 805M51000247 805M51000248 805M51000249 806M51000250 806M51000251 806M51000252 806M51000253 806M51000254 806M51000255 806M51000256 806M51000257 806M51000258 806M51000259 806M51000260 806M51000261 806M51000262 806M51000263 806M51000264 806M51000265 806M51000266 806M51000267 806M51000268 806M51000269 806M51000270 806M51000271 806M51000272 806M51000273 806M51000274 807M51000275 807M51000276 807M51000277 807M51000278 807M51000279 807M51000280 807M51000281 807M51000282 807M51000283 807M51000284 807M51000285 807M51000286 807M51000287 807M51000288 807M51000289 807M51000290 807M51000291 807M51000292 807M51000293 807M51000294 807M51000295 807M51000296 807M51000297 807M51000298 807M51000299 807M51000300 807M51000301 807M51000303 807M51000304 807M51000305 807M51000306 807M51000307 807M51000308 807M51000309 807M51000310 807M51000311 807M51000313 807M51000314 807M51000315 807M51000316 807M51000317 807M51000318 807M51000319 807M51000320 807M51000321 807M51000322 807M51000323 807M51000324 808M51000325 808M51000326 808M51000327 808M51000328 808M51000329 808M51000330 808M51000331 808M51000332 808M51000333 808M51000334 808M51000335 808M51000336 808M51000337 808M51000338 808M51000339 808M51000340 808M51000341 808M51000342 808M51000343 808M51000344 808M51000345 808M51000346 808M51000347 808M51000348 808M51000349 810M51000350 810M51000351 810M51000352 810M51000353 810M51000354 810M51000355 810M51000356 810M51000357 810M51000358 810M51000359 810M51000360 810M51000361 810M51000362 810M51000363 810M51000364 810M51000365 810M51000366 810M51000367 810M51000368 810M51000369 810M51000370 810M51000371 810M51000372 810M51000373 810M51000374 811M51000375 811M51000376 811M51000377 811M51000379 811M51000380 811M51000381 811M51000382 811M51000383 811M51000384 811M51000385 811M51000386 811M51000387 811M51000388 811M51000389 811M51000390 811M51000391 811M51000392 811M51000393 811M51000394 811M51000395 811M51000396 811M51000397 811M51000398 811M51000399 813M51000400 813M51000401 813M51000402 813M51000403 813M51000404 813M51000405 813M51000406 813M51000407 813M51000408 813M51000409 813M51000410 813M51000411 813M51000412 813M51000413 813M51000414 813M51000415 813M51000416 813M51000417 813M51000418 813M51000419 814M51000420 814M51000421 814M51000422 814M51000423 814M51000424 814M51000425 814M51000426 814M51000427 814M51000428 814M51000429 814M51000430 814M51000431 814M51000432 814M51000433 814M51000434 814M51000435 814M51000436 814M51000437 814M51000438 814M51000439 817M51000440 817M51000441 817M51000442 817M51000443 817M51000444 817M51000445 817M51000446 817M51000447 817M51000448 817M51000449 817M51000450 817M51000451 817M51000452 817M51000453 817M51000454 817M51000455 817M51000456 817M51000457 817M51000458 817M51000459 818M51000460 818M51000461 818M51000462 818M51000463 818M51000464 818M51000465 818M51000466 818M51000467 818M51000468 818M51000469 818M51000471 818M51000472 818M51000473 818M51000474 818M51000475 818M51000476 818M51000477 818M51000478 818M51000479 820M51000480 820M51000481 820M51000482 820M51000483 820M51000484 820M51000485 820M51000486 820M51000487 820M51000488 820M51000489 820M51000490 820M51000491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  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia Belgium, Czech Republic, Finland, France, Greece, Kuwait, Norway, Turkey,UK, and Norway.
  • Product Description
    Statspin Express 4 Centrifuge || Model Number: SSH4 || Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes
  • Manufacturer

Manufacturer

  • Manufacturer Address
    StatSpin, Inc., dba Iris Sample Processing, 60 Glacier Dr, Westwood MA 02090-1800
  • Manufacturer Parent Company (2017)
  • Source
    USFDA