CLASS II Device recall · Reported 6 Jan 2016 · FDA Enforcement Report
MicroScan Pos Breakpoint Combo Panel Type recalled by Beckman Coulter
Beckman Coulter is recalling MicroScan Pos Breakpoint Combo Panel Type 20, distributed nationwide in the US. The recall was initiated on 1 Dec 2015 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-0561-2016
- FDA event ID
- 72779
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2015
- FDA classified
- 30 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Listeria
- Device type
- Other Medical Devices
Timeline
| 1 Dec 2015 | Recall initiated by company | |
| 30 Dec 2015 | Classified by FDA | +29 days |
| 6 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Listeria monocytogenes can grow at refrigerator temperatures. Infection is most dangerous for pregnant women, newborns, older adults and people with weakened immune systems. Symptoms can appear up to 70 days after eating contaminated food.
Product as listed by the FDA
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 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.
Where it was distributed
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
Questions about this recall
Is MicroScan Pos Breakpoint Combo Panel Type 20 recalled?
Yes. Beckman Coulter recalled MicroScan Pos Breakpoint Combo Panel Type 20 on 1 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0561-2016.
Why was it recalled?
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.
Which lots are affected?
2016-04-30 Part No. B1017-202
Where was it sold?
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
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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