Dimension Vista¿ MULTI 2 SDIL recall
Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
Why was Dimension Vista¿ MULTI 2 SDIL recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot 7CDA79, UDI # (UDI) 008427680324177CDA7918090110483586, exp 2018-09-01; lot # 7DDA70, UDI # (UDI) 008427680324177DDA7018110110483586, exp 2018-11-01
- Product
- Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1195
- 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: Australia, Austria, Bahamas, Belgium, Brazil, Canada, Canary Islands, Croatia, Czech Republic, Denmark, France, Germany, Italy, Japan, Lebanon, Netherlands, Poland, Portugal, Qatar, Russian Federation, Slovakia, Slovenia, Saudi Arabia, South Korea, Spain, Switzerland, and United Arab Emirates.
- Recall date
- July 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)