AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01
This recall has been terminated (originally issued August 22, 2007).
- Recall Initiated
- May 31, 2007
- Posted
- August 22, 2007
- Terminated
- June 10, 2011
- Recall Number
- Z-1185-2007
- Quantity
- 267
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Controls Out of Range/Specification .
Distribution
Worldwide: USA including states of AR, AZ, CA, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OK, OR, SC, TN, TX, VA, WA, WI, WV, Hawaii and Puerto Rico. International: CANADA, GERMANY, JAPAN, SINGAPORE, AUSTRALIA, and BARBADOS
Lot / Code Info
Lot # 44794Q100 Exp. Date: 08/09/2007 and Lot # 47093Q100 Exp. Date: 10/10/2007
Root Cause
Other
Action Taken
May 31, 2007, Product Correction Letter to Customers were instructed to: "Revise the expiration date for all lots identified in the customer letter. "Discontinue use of the expired lots, and discard the material according to their laboratory procedures. "An additional option is to use the Abbott Immunoassay Multiconstituent Control (List Number 06E20), manufactured by BIO-RAD.