Recall Z-2436-2018
Siemens Healthcare Diagnostics, Inc. · initiated March 21, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
Codes / lots: lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205
Reason for recall
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
FDA-determined cause: Under Investigation by firm
Action taken
Notification letters were distributed 3/21/18. The letters instructed customers to: Inspect stock, discontinue use of and discard the Dimension Vista Diluent lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.
Details
- Recall number
- Z-2436-2018
- Initiated
- March 21, 2018
- Terminated
- June 12, 2020
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 1446
- Distribution
- The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to Guam, Saipan, and Virgin Islands. The products were distributed to the following countries:…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2437-2018 Class II | Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective… | 03/21/2018Terminated |
| Z-2438-2018 Class II | Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective… | 03/21/2018Terminated |