G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usa
FDA device recall Z-2066-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Tosoh Bioscience, Inc.
- Reason for recall
- The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
- Action taken
- Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 9 boxes/5 pouches
- Distribution
- Us Nationwide Distribution in the state ID including PR.
- Date initiated
- 2015-02-10
- Date posted
- 2015-07-14
- Date terminated
- 2015-10-01
- Location
- South San Francisco, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G7 AUTOMATED HPLC ANALYZER (K011434) | Tosoh Medics, Inc. | 2001-09-18 |