Recall Z-1789-2010
Biosite Inc · initiated February 6, 2009
Product
Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp <-20C. Intended use: Assayed materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to assist in monitoring test performance.
Codes / lots: Model 88754 Lots C1919A, C1933A, C1934A & C2001A
Reason for recall
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
FDA-determined cause: Other
Action taken
The firm, Biosite Incorporated, sent an "URGENT MEDICAL DEVICE RECALL" dated February 6, 2009, to all customers. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to immediately discontinue all use and/or sale of the listed products, discard all affected product in accordance with their local regulations, complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice, to indicate the number of kits discarded from their inventory and the product replacement will be sent to them. Contact Inverness Medical Technical Service at 1-877-441-7440 and select option 2 from the phone prompt and a representative will confirm the number of kits discarded from your inventory and arrange for replacement product to be sent to you. Should you have any questions about the information contained in this notification, please contact (877) 441-7440 or email: Recalls@biosite.com
Details
- Recall number
- Z-1789-2010
- Initiated
- February 6, 2009
- Posted by FDA
- June 11, 2010
- Terminated
- September 1, 2011
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Distribution
- Nationwide distribution
- Recalling firm
- Biosite Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1788-2010 | Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp <-20C. Intended use:…Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in… | 02/06/2009Terminated |
| Z-1790-2010 | Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five…Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in… | 02/06/2009Terminated |