HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hac
FDA device recall Z-2016-2009 · posted 2009-09-04 · Terminated
Recall details
- Recalling firm
- Hach Co
- Reason for recall
- Some of the reagent strip bottles contain the incorrect strips
- Action taken
- Hach Company issued an "Urgent Medical Device Recall" letter dated April 21, 2009 explaining the reason for recall and requested product remaining in inventory be returned. Subrecall to the end-user level was requested. A Return Form was also enclosed to be completed to indicate the amount of product being returned. Between April 22-23, 2009, the firm telephoned their customers to assure they received the recall letter. For further information, contact Hach Customer Service at 1-800-548-4381 extension 3560.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LIF
- Quantity affected
- 275 kits
- Distribution
- Nationwide Distribution -- NJ, CA, IN, PA, NV, CA, and ME.
- Date initiated
- 2009-04-21
- Date posted
- 2009-09-04
- Date terminated
- 2009-10-07
- Location
- Ames, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (K974798) | Environmental Test Systems, Inc. | 1998-03-20 |