Laboratory diagnostic device software issue may delay clinical diagnosis
BD Kiestra InoqulA+ (software versions 5.1/5.1.1) fails to display plate information after processing in clinical laboratories, risking diagnostic delays or specimen recollection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported patient illnesses or injuries. The software malfunction creates risk of delayed diagnosis and may require specimen recollection, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling BD Kiestra InoqulA+ laboratory diagnostic devices running software versions 5.1 and 5.1.1 as part of the Icefall A platform. After specimen processing, the devices fail to display plate information in the Synapsys software system, preventing laboratory personnel from viewing processed results.
The failure to display processed plate information could lead to delayed patient diagnosis and treatment, or require recollection and reprocessing of specimens. The devices automate laboratory specimen processing including plate streaking and inoculation of tubes and slides in clinical laboratory settings.
Seven affected instruments have been recalled. Serial numbers affected include INO-000156, INO-000249, INO-000248, INO-000252, INO-000254, 20130276, and 19033ST002 (UDI: 038290LSUVLPKFPV). Distribution includes US locations in Illinois and New York, and international locations in the Netherlands and Saudi Arabia.
The recalled product
- Product
- BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as part of the Icefall A platform. An in vitro diagnostic medical device intended to automate specimen processing according to user-defined procedures and protocols. Catalog (Ref) No. : 447213
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- diagnostic-delay
- system-malfunction
- specimen-recollection
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI: 038290LSUVLPKFPV Serial Numbers: INO-000156
- INO-000249
- INO-000248
- INO-000252
- INO-000254
- 20130276
- 19033ST002
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03