Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470
FDA device recall Z-1434-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
- Action taken
- Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CKH
- Quantity affected
- 728 non-expired kits.
- Distribution
- Nationwide.
- Date initiated
- 2004-08-20
- Date posted
- 2004-09-02
- Date terminated
- 2004-11-05
- Location
- Indianapolis, IN
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