FDA Device Recalls

Class IITerminated

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

Randox Laboratories Ltd.

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

June 22, 2022 · DeviceView details →

Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.

Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF

SX-One MicroKnife

Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF

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LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

nordicBrainEX, software versions 2.21 through 2.3.10

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.

Centricity PACS Software Version 7.0 SP0.0.4.7

RayStation 11B

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.

Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.

DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.