Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing
FDA device recall Z-0217-2007 · posted 2006-12-08 · Terminated
Recall details
- Recalling firm
- Biogenex Laboratories
- Reason for recall
- Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.
- Action taken
- The firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- NJT
- Quantity affected
- 158 units
- Distribution
- Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
- Date initiated
- 2006-10-03
- Date posted
- 2006-12-08
- Date terminated
- 2007-12-04
- Location
- San Ramon, CA
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