SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
This recall has been terminated (originally issued July 21, 2017).
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- July 21, 2017
- Terminated
- June 19, 2020
- Recall Number
- Z-0045-2020
- Quantity
- 24 kits
- Firm Location
- Beaumont, TX
- Official Source
- View on FDA website ↗
Reason for Recall
The plates do not have wells punched for the controls in the patient 1 area.
Distribution
Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
Lot / Code Info
Lot 35-17-552583, exp. date 4/30/2018
Root Cause
Employee error
Action Taken
The recall was initiated via phone on 7/21/2017 requesting the customer return the product for replacement if they routinely use the control wells.
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