Reported May 6, 2015 · Terminated
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information…
Biocare Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocare Medical, LLC · 4040 Pike Ln · Concord, CA · 94520-1227
Is this the product you have?
- CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use
- Product UsageProvides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods
- Lot codes and dates
- Catalog number PM008 AA
- Lot numbers
110912Exp 2015/11041913Expiry 2016/04120313Expiry 2016/12110314Expiry 2017/11
- Amount recalled
- 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Where it was sold
Why it was recalled
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
This product could cause temporary or reversible health problems — stop using it.
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