—#179235

Product

PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).

Affected lot / code info: Instrument Serial Number AS180-00028 1035196 AS180-00067 1007580 AS180-00084 2055833 AS180-00105 2025461 AS180-00138 2025461 AS180-00179 1039938 AS180-00217 1033454 AS180-00248 1029262 AS180-00278 1031886 AS180-00300 1033400 AS180-00306 1034034 AS180-00326 1034190 AS180-00336 1041241 AS180-00339 2054793 AS180-00357 2055775 AS180-00381 1073849 AS180-00385 1054234 AS180-00398 1052053 AS180-00402 2055620 AS180-00405 1063739 AS180-00418 1042188 AS180-00420 1040343 AS180-00428 1030890 AS180-00453 1031472 AS180-00468 1043640 AS180-00476 1029272 AS180-00478 1053432 AS180-00479 1011691 AS180-00480 5001554 AS180-00481 1039588 AS180-00482 1034363 AS180-00483 1029990 AS180-00484 1049298 AS180-00485 AU01 AS180-00486 1047965 AS180-00487 1074074 AS180-00488 1000283 AS180-00489 1035594 AS180-00490 1047965 AS180-00491 1035549 AS180-00492 1070878 AS180-00493 1090075 AS180-00494 1039290 AS180-00495 1029148 AS180-00500 1007884 AS180-00509 1065153

Why it was recalled

The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm initiated the recall by letter on 01/15/2020. The Urgent Product Correction Notice instructed the customer the to provide the letter to all appropriate personnel within their organization. The letter instructs the personnel to check their inventory against the serial numbers listed in Appendix A of the letter. The letter also details that a bioMerieux Field Service Engineer will be contacting the customer to schedule a service appointment and if necessary, replace the PSU.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.

Timeline

Recall initiated: 2020-01-24
Terminated: 2023-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179235. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.