CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
Vitros Chemistry Products Ckmb Slides, Creatine Kinase MB, Product recalled
Ortho-Clinical Diagnostics is recalling Vitros Chemistry Products Ckmb Slides, Creatine Kinase MB, distributed nationwide in the US. The recall was initiated on 1 Apr 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-1931-2020
- FDA event ID
- 85363
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2020
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 1 Apr 2020 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +37 days |
| 20 May 2020 | 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
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Which lots are affected?
CKMB Slides that expire after July 20, 2018 and within current expiry.
Where was it sold?
US Nationwide distribution.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85363| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Vitros Chemistry Products Ckmb Slides, Creatine Kinase MB, Product recalled | Ortho-Clinical Diagnostics | Potency & Assay | Nationwide |
More recalls from Ortho-Clinical Diagnostics
All 311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products LAC Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products Ca Slides recalled | Ortho-Clinical Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides (Japan) recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
| Device | CLASS II | Vitros Chemistry Products CHE Slides recalled | Ortho-Clinical Diagnostics | Labeling Errors | Nationwide |
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