MicroScan Pos Breakpoint Combo Panel Type 23 — Class II medical device recall Z-0562-2016

Terminated recall by Beckman Coulter Inc., reported 2016-01-06, distributed nationwide. Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) wi

Recall number	`Z-0562-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Beckman Coulter Inc., Brea, CA, United States
Recall initiated	2015-12-01
Classified	2015-12-30
Reported by FDA	2016-01-06
Terminated	2016-07-29
Distributed	Nationwide (US)
Countries outside the US	AT, BE, BR, CA, DE, ES, GB, IT, JP, KW, MX, NL, NO, PA, PL, PT, RO, TH, TW
Pathogens	staphylococcus
Model numbers	`B1017-206`

Product

MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Reason for recall

Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0562-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.