Abbott Health Products, Inc. IMx HAVAB Controls In Vitro Test Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMx HAVAB Controls In Vitro Test
Brand
Abbott Health Products, Inc.
Lot Codes / Batch Numbers
Lot # 21059Q100 Expiration Date: May 20, 2005
Products Sold
Lot # 21059Q100 Expiration Date: May 20, 2005
Abbott Health Products, Inc. is recalling IMx HAVAB Controls In Vitro Test due to Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026