SPIFE ImmunoFix-6 Kit recall
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Why was SPIFE ImmunoFix-6 Kit recalled?
The plates do not have wells punched for the controls in the patient 1 area.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 35-17-552583, exp. date 4/30/2018
- Product
- SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 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.
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)