Recall Z-1668-2011
Abbott Laboratories · initiated September 30, 2010
Product
Abbott brand CELL-DYN Emerald Diluent Reagent, 10 mL, List Number: 09H48-02, Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara. CA Designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
Codes / lots: Lot Number: 4350, Expiration Date: June 30, 2012
Reason for recall
The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.
FDA-determined cause: Error in labeling
Action taken
Product Recall notification letters were sent on 9/30/2010. The letter identified the affected product, an explanation of the problem, patient impact, and necessary actions. Consignees are to contact their local hematology customer support representative to arrange for replacement of the CELL-DYN Emerald Diluent Lot. Once the replacement lot has been received, customers should destroy the affected lot according to their laboratory procedures. A copy of the letter should be retained for their records and the Customer Reply Form should be completed and returned via fax or e-mail. US customers should contact Customer Support at 1-877-4ABBOTT, if they have questions.
Details
- Recall number
- Z-1668-2011
- Initiated
- September 30, 2010
- Posted by FDA
- March 17, 2011
- Terminated
- April 7, 2011
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 322 units
- Distribution
- Worldwide Distribution -- USA, including states of PA, NY, CA, NC, IL, TX, KS, UT, VA, FL, AR, TN, MN, NE, MI, and DE and the country of Germany.
- Recalling firm
- Abbott Laboratories, Santa Clara, CA