AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium
FDA device recall Z-1186-2007 · posted 2007-08-22 · Terminated
Recall details
- Recalling firm
- Abbott Diagnostic International, Ltd.
- Reason for recall
- Controls Out of Range/Specification .
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LGI
- Quantity affected
- 119
- 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
- Date initiated
- 2007-05-31
- Date posted
- 2007-08-22
- Date terminated
- 2011-06-10
- Location
- Barceloneta, PR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXSYM(TM) QUINIDINE (K940682) | Abbott Laboratories | 1994-06-21 |