CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls
FDA device recall Z-0328-2016 · posted 2015-11-23 · Terminated
Recall details
- Recalling firm
- Biochemical Diagnostics Inc
- Reason for recall
- CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
- Action taken
- Biochemical Diagnostics sent a Notice of Correction Letter (dated August 26, 2015) to customers via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return the verification form, per the notification. For questions contact Alere Technical Service at 866-216-0094 or by email at verifications.at verifications.ts@alere.com.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- Domestic: 4,473 kits
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-09-14
- Date posted
- 2015-11-23
- Date terminated
- 2016-01-26
- Location
- Edgewood, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREGNANCY-SKREEN (K050328) | Biochemical Diagnostic, Inc. | 2005-03-29 |