Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum.
FDA Recall Z-0860-2010 · Posted 2010-02-25
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Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeLBR
Date Initiated2009-11-10
Date Terminated2011-02-11
Product Quantity237 sets plus 9L
Reason for Recall
The firm initiated the recall due to the presence of visible contamination of the product.
Firm Action
Consignees were notified by an Urgent: Medical Device Recall letter (sent by email, fax or through the mails) dated 11/10/09. The letter identified the affected product and instructed customers to immediately examine their inventory. If the product was further distributed their customers should be identified and notified of the recall. Customers are instructed to dispose of any product in stock. Questions should be directed to the Technical Support Department at 800-757-5313 or 734-487-8300.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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