Background Information Regarding the ISBT Label
Useful References
- Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels - 9/22/2006
- United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 - 9/22/2006 (PDF, 1.6 MB)
- ISBT Label Checklist for Licensed Establishments
In the following table, we are providing blood establishments with correct ISBT label information to expedite the review process where we anticipate potential errors in labeling submissions. Please use this table to make necessary corrections to labeling before submitting to CBER labeling for approval.
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®Common Errors found in ISBT Label Submissions
| Item | Incorrect | Correct | Guidance Document Reference #1 (PDF, 1.6 MB) |
|---|---|---|---|
| Abbreviated legal name | Community Blood Bk of E. Anytown, Inc. | Community Blood Bank of East Anytown, Inc. | |
| Full legal name is not present on label | Blood Bank | Blood Bank, Inc. | Pg. 27 |
| No license number on label | US License Number 9999 | Pg. 27 | |
| Divided Units | Nothing present in code. For example: E4520V00 | On divided units the code should have an A, B, or C indicating divided (E4520VA0) but additionally the term Divided should be on the label in the attribute line. | Pg. 18 - 19 |
| Bacterial Monitoring | APHERESIS PLATELETS LEUKOCYTES REDUCED |
Bacterial monitoring translates to 7d on the label
APHERESIS |
Pg. 75 |
| Collection Date on products with no expiration date or Recovered Plasma | No collection date | The collection date goes in the upper left quadrant of the label if applicable | Pg. 28 |
| Expiration Date and Time on products that are NOT time dependent | 22 Jan 2005 2359 | 22 Jan 2005 Note: The hour should not be displayed if time >72 hours. |
Pg. 15 |
| Plasma Frozen ≤ 24 hours | Frozen within 24 hours of phlebotomy | Frozen within 24 hours after phlebotomy | Pg. 74-75 |
| Donor Identification Number | Incorrect facility code used | Correct facility code | Pg. 27 |
| Donor Identification Number | If firm uses “doing business as name” to match the facility code | Facility code must match the legal name not dba name | |
| Donor Identification Number | Font size and prominence are not the same throughout the entire number | Same font size throughout the entire number | Pg. 27 |
| Rx Only | Rx Only. or Rx ONLY. | Rx Only | Pg. 27 |
| Rx ONLY or Rx only | Rx Only | Pg. 27 | |
| RX ONLY | Rx Only | Pg. 27 | |
| Degree symbol in the temperature | 1 – 6◦C | 1 – 6 C | Pg. 29 |
| Periods after abbreviations | Approx. or mL. | Approx or mL | Pg. 51-53 |
| Periods after temperature and anticoagulant statements | Store at 1 to 6 C. From 500 mL CPD Whole Blood. |
Store at 1 to 6 C From 500 mL CPD Whole Blood |
Pg. 51-53 |
| Legal name in all capital letters | BLOOD BANK, INC. | Blood Bank, Inc. | Pg. 27 |
| Firm’s city in all capital letters | ANYTOWN | Anytown | Pg. 27 |
| Hash marks through zeros | Ø | 0 | |
| Extra zeroes in numbers | 023mL | 23mL | |
| Autologous statement | for AUTOLOGOUS use only | FOR AUTOLOGOUS USE ONLY | Pg. 15, 30, 48 |
| Biohazard statement in different font | BIOHAZARD |
BIOHAZARD |
Pg. 15, 30, 48 |
| Caution statement in different font sizes or Circular of Information not capitalized | See circular of information for indications, contraindications, cautions and methods of infusion. | See Circular of Information for indications, contraindications, cautions and methods of infusion. | Pg. 27 |
| Period after Properly Identify Intended Recipient | Properly Identify Intended Recipient. | Properly Identify Intended Recipient | Pg. 40 |
| Lower Right Quadrant | Facility name, registration number and license number | This quadrant should be blank unless the firm has further manufacturing done by another facility then that facility information should be present | Pg. 31 |
| Facility information in upper right quadrant | Collected and Processed by: | Nothing – remove statement | Pg. 27 |
Optional Statements on Labels:
| Item | Comment | Guidance Document Reference, if applicable |
|---|---|---|
| Cryoprecipitate Labels | The standard does not address putting the statement “From 500 (or 450) mL Whole Blood” on the label but this is acceptable if the code states it is from Whole Blood – code dependent | Pg. 53 shows label without verbiage |
| Residual Leukocyte Count | The residual leukocyte count should be written with a superscript only. The firm may NOT use the carrot top with a regular 6 or the notation e in front of the 6. If printed, this should be below the storage temperature. | Pg. 73 |
| mEq statement on Codabar labels for AS RBCs | This statement does NOT go on ISBT labels. | |
| Properly Identify Intended Recipient | This statement is approvable if it is in all capital letters as follows: PROPERLY IDENTIFY INTENDED RECIPIENT | |
| Facility Name and Address | It is approvable for the facility information to contain the street address, zip code or a phone number in the upper left quadrant. Per the guidance document only the city and state are required. | Pg. 28 |