Reported Jun 3, 2015 · Terminated
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a…
Biocare Medical, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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?
- D2-40 (Lymphatic Marker); For In Vitro Diagnostic
- Catalog numberPM266AA
- Product UsageIn Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues
- Lot codes and dates
- Catalog number
PM266AAlot 030615
- Expiration2018/03
- Catalog number
- Amount recalled
- 19 units
Where it was sold
Why it was recalled
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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