CLASS II Device recall · Reported 29 Apr 2020 · FDA Enforcement Report
Previ Isola Insrument and Previ Isola Printer spares PSUs recalled
bioMerieux is recalling Previ Isola Insrument and Previ Isola Printer spares PSUs (power supply units), distributed nationwide in the US. The recall was initiated on 24 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1793-2020
- FDA event ID
- 84737
- Recalling firm
- bioMerieux, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2020
- FDA classified
- 23 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jan 2020 | Recall initiated by company | |
| 23 Apr 2020 | Classified by FDA | +90 days |
| 29 Apr 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.
Questions about this recall
Is Previ Isola Insrument and Previ Isola Printer spares PSUs (power supply units) recalled?
Yes. bioMerieux recalled Previ Isola Insrument and Previ Isola Printer spares PSUs (power supply units) on 24 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1793-2020.
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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