Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positi
FDA device recall Z-0908-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories
- Reason for recall
- Elevated optical density (OD) values with the kit Negative Control.
- Action taken
- An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LFX
- Quantity affected
- 82 kits
- Distribution
- Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
- Date initiated
- 2008-08-20
- Date posted
- 2010-03-02
- Date terminated
- 2010-04-08
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SERAQUEST RUBELLA IGG (K961053) | Quest Intl., Inc. | 1996-09-04 |