SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reported: October 16, 2019 Initiated: July 21, 2017 #Z-0045-2020
Product Description
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for Recall
The plates do not have wells punched for the controls in the patient 1 area.
Details
- Recalling Firm
- Helena Laboratories, Corp.
- Units Affected
- 24 kits
- Distribution
- Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.
- Location
- Beaumont, TX
Frequently Asked Questions
What product was recalled? ▼
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.. Recalled by Helena Laboratories, Corp.. Units affected: 24 kits.
Why was this product recalled? ▼
The plates do not have wells punched for the controls in the patient 1 area.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0045-2020.
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