BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials
FDA device recall Z-1502-2012 · posted 2012-05-09 · Terminated
Recall details
- Recalling firm
- MichClone Associates, Inc.
- Reason for recall
- Two complaints received concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing and nasal congestion. Investigation found no affect on the perf
- Action taken
- Michclone Associates, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated March 15, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to identify affected lots, notify sub accounts, and complete and return the response form to arrange return of unused product and replacement . Forms can be returned by FAX 248(307)-9498, mail: Michclone Associates Inc. 680 Ajax Drive, Madison Heights, MI 48118 or Email: toben@greatlakesdiag.com. Questions and concerns should be addressed to Technical Support Department at 248-307-9494.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GHM
- Quantity affected
- 250
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-02-23
- Date posted
- 2012-05-09
- Date terminated
- 2012-12-13
- Location
- Madison Heights, MI
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SICKLE CELL REAGENT SET (K860812) | Michclone Associates, Inc. | 1986-04-11 |