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U.S. Department of Health and Human Services

Class 2 Device Recall PREVI Isola Instrument

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 Class 2 Device Recall PREVI Isola Instrumentsee related information
Date Initiated by FirmJanuary 24, 2020
Create DateApril 23, 2020
Recall Status1 Terminated 3 on January 11, 2023
Recall NumberZ-1793-2020
Recall Event ID 84737
ProductPREVI 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).
Code Information 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  
FEI Number 3002769706
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact
919-620-2000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
DistributionWorldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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