Biosite Inc Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use: Materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify the calibration of the Test Devices throughout the measurable range. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different levels (A,B,C,D,E). Storage Temp <-20C. Intended use: Materials used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
Brand
Biosite Inc
Lot Codes / Batch Numbers
Model 88755 Lots 194444 & 194450
Products Sold
Model 88755 Lots 194444 & 194450
Biosite Inc is recalling Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes for each of five different lev due to Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026