Recall Z-1375-2015— BD Biosciences, Systems & Reagents
Class II · Terminated
Class II FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2015-03-23, terminated 2016-02-26. FDA's recall record names no specific 510(k) clearance for this event. Product: CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent. Reason: One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern..
- Recalling firm
- BD Biosciences, Systems & Reagents
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-23
- Terminated
- 2016-02-26
- Firm location
- San Jose, CA, United States
Product description
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Reason for recall
One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.
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