TECHNICAL BULLETIN

Professional Services | Roche Care Center

201 Armand-Frappier Blvd, Laval, Quebec, H7V 4A2
_____________________________________________________________________________________________
Date June 2014 CC2014917
Subject PreciControl ClinChem Multi 1 and 2: Canadian specific values
for Direct Bilirubin Gen.2 (BILD2)
Systems MODULAR ANALYTICS <P>, COBAS INTEGRA® 400plus and 800,
cobas c111/311/501/502/701/702
Attachment N/A

Affected products name Product no. Lots / Expiration

PreciControl ClinChem Multi 1 05117003190 172687-92 / 2016-01
172206-11 / 2016-01
PreciControl ClinChem Multi 2 05117216190
172694-99 / 2016-01

Subject
This bulletin provides Canadian specific control values for of PreciControl ClinChem Multi 1 and
2 to be used with Bilirubin Direct generation 2. (Application short name DBIL2).

Action required on your analyzer

Use the following values to manually update the controls values for in your system.
Refer to your operator manual for instrument specific instructions.

Controls Instruments ACN Lots no. Target Range 1 SD Units

172687 12.9 9.8 16.0 1.0
172688 12.9 9.8 16.0 1.0
INTEGRA400+/800 735 172689 12.8 9.7 15.9 1.0
cobas c 111/311/501 735 µmol ∕ L
cobas c 502/701/702 8735 172690 12.9 9.8 16.0 1.0
172691 12.8 9.8 15.9 1.0
172692 12.8 9.7 15.9 1.0
PCCM 1
172687 14.1 10.7 17.4 1.1
172688 14.0 10.6 17.3 1.1
172689 13.9 10.6 17.3 1.1
MODULAR P 727 µmol ∕ L
172690 13.9 10.6 17.3 1.1
172691 13.9 10.6 17.2 1.1
172692 13.8 10.5 17.2 1.1

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Controls Instruments ACN Lots no. Target Range 1 SD Units
172206 32.5 24.7 40.3 2.6
172207 32.3 24.6 40.1 2.6
172208 32.5 24.7 40.3 2.6
172209 32.3 24.6 40.1 2.6
172210 32.3 24.6 40.1 2.6
INTEGRA400+/800 735 172211 32.3 24.6 40.1 2.6
cobas c 111/311/501 735 µmol ∕ L
cobas c 502/701/702 8735 172694 32.0 24.3 39.7 2.6
172695 32.0 24.3 39.7 2.6
172696 31.8 24.2 39.4 2.5
172697 32.0 24.3 39.7 2.6
172698 32.0 24.3 39.7 2.6
172699 31.8 24.2 39.4 2.5
PCCM 2
172206 35.2 26.8 43.7 2.8
172207 34.9 26.5 43.3 2.8
172208 35.1 26.6 43.5 2.8
172209 34.9 26.5 43.3 2.8
172210 34.9 26.5 43.3 2.8
172211 34.7 26.4 43.0 2.8
MODULAR P 727 µmol ∕ L
172694 34.7 26.4 43.0 2.8
172695 34.4 26.1 42.6 2.7
172696 34.4 26.1 42.6 2.7
172697 34.5 26.3 42.8 2.8
172698 34.5 26.3 42.8 2.8
172699 34.4 26.1 42.6 2.7

Action required
· Please note that the values for the Canadian Direct Bilirubin Gen.2 applications
(ACNs : 735, 8735 and 727) are not listed in the value sheet included in kits of affected
lots and will not be updated.
· Use the values listed above to manually update the new target and ranges on your
analyzer.
· Keep this document for future reference.

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Questions
Should you need more information, please do not hesitate to contact the Roche Care Center at
1-877-273-3433 or (450) 686-7111 and also by e-mail at laval.techinfo@roche.com.
Thank you for your continued support of Roche Diagnostics.

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