Device Recall

Lot numbers: 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D (exp. date 2017-06-13); 6JQL01A, 6JQL01B, 6JQL01C (exp. date 2018-01-31). --- Lot # (UDI): 6BQL01 (008427680063336BQL0120170613),  6BQL01A (008427680063406BQM01A20170617),  6BQL01B (008427680063406BQM01B20170617),  6BQL01C (008427680063406BQM01C20170617),  6BQL01D (008427680063406BQM01D20170617),  6JQL01A (008427680063336JQL01A20180131),  6JQL01B (008427680063336JQL01B20180131),  6JQL01C (008427680063336JQL01C20180131).

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD

Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) ---  Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131),  6BQM01A (008427680063406BQM01A20170617),  6BQM01B (008427680063406BQM01B20170617),  6BQM01C (008427680063406BQM01C20170617),  6BQM01D( 008427680063406BQM01D20170617),  6BQM01E (008427680063406BQM01E20170617),  6FQM01(008427680063406FQM0120171103),  6FQM01A (008427680063406FQM01A20171103).

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD

Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). ---  Lot # (UDI): 6EQH01 (008427680063576EQH0120170917),  6EQH01A (008427680063576EQH01A2017091),  6EQH01B(008427680063576EQH01B20170917),  6EQH01C(008427680063576EQH01C20170917),  6LQH01A (008427680063576LQH01A20180404),  6LQH01B (008427680063576LQH01B20180404),  6LQH01C (008427680063576LQH01C20180404).

Immunology and Microbiology Devices

2

No

Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South

Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.

Serial Number: 100873

General Hospital and Personal Use Devices

1

No

U.S. Distribution: TX only

3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 || The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.

Catalog Number 8L24-31: Lot Numbers: 60335Y600, 60382Y600 (Exp. Date 2018-02-28); Catalog Number 8L24-41: Lot Number: 60334Y600, (Exp. Date 2018-02-28)

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems || The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2