CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report
BS-200 Chemistry Analyzer Designed for clinical laboratory use recalled
Mindray DS USA, Inc. d.b.a. Mindray North America is recalling BS-200 Chemistry Analyzer Designed for clinical laboratory use, distributed in North Carolina, Texas. The recall was initiated on 28 Nov 2012 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-0977-2013
- FDA event ID
- 64112
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Nov 2012
- FDA classified
- 22 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Nov 2012 | Recall initiated by company | |
| 22 Mar 2013 | Classified by FDA | +114 days |
| 3 Apr 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Product as listed by the FDA
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Where it was distributed
Distributed in the states of NC and TX.
Questions about this recall
Is BS-200 Chemistry Analyzer Designed for clinical laboratory use recalled?
Yes. Mindray DS USA, Inc. d.b.a. Mindray North America recalled BS-200 Chemistry Analyzer Designed for clinical laboratory use on 28 Nov 2012. The recall is Class II and its status is Terminated. Recall number Z-0977-2013.
Why was it recalled?
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Which lots are affected?
Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
Where was it sold?
Distributed in the states of NC and TX.
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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