Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes.
FDA device recall Z-0932-2017 · posted 2016-12-29 · Terminated
Recall details
- Recalling firm
- Sterling Diagnostics, Inc.
- Reason for recall
- Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
- Action taken
- Sterling Diagnostics, Inc. initiated their voluntary recall on 07/20/2016 by calling customers by phone to determine what kits remianed at customers' and compare withthe firm's sales records. Sterling Diagnostics followed up by sending a letter to each customer, and instructed them to take note of the corrected expiration dates for the dignostic kits, apply the revised dates to the kits in their possession, and return a customer acknowledgement to the Office Manager Luz Santa Maria at Sterling Diagnostics, Inc. at 36645 Metro Court, Sterling Heights, MI 48312. Customers with questions can call 586-979-2141.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 40
- Distribution
- Domestic: MI Foreign: Phillipines VA/DOD: None
- Date initiated
- 2016-07-20
- Date posted
- 2016-12-29
- Date terminated
- 2017-03-22
- Location
- Sterling Heights, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUCOSE REAGENT SET (GOD/TRINDER) (K854335) | Sterling Diagnostics, Inc. | 1985-11-22 |