CD99 Catalog number PM008 AA recall
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis…
Why was CD99 Catalog number PM008 AA recalled?
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
- Product
- CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis…
- Recalling firm
- Biocare Medical, LLC
- Quantity
- 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
- Distribution
- Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel.
- Recall date
- May 6, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)