IMx HAVAB Controls In Vitro Test
FDA device recall Z-0660-05 · posted 2005-03-29 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.
- Action taken
- Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 373 Kits
- Distribution
- The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore.
- Date initiated
- 2005-03-04
- Date posted
- 2005-03-29
- Date terminated
- 2005-09-29
- Location
- Barceloneta, PR
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